MenorrhagiaNCT00864136
Mirena or Conventional Medical Treatment for Menorrhagia
An observational study of Menorrhagia, run by Bayer at 8 sites in 8 countries.
Trial summary
The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Mirena in treatment of prolonged or heavy menstrual bleeding (Menorrhagia) under daily-life treatment conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Levonorgestrel (Mirena, BAY86-5028) and Conventional medical treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 647 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Nov 2008to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with a diagnosis of idiopathic menorrhagia can be enrolled after decision for treatment has been made.
Who may be able to join
- Women between the ages of 18-45 (inclusive) not intending to get pregnant during the next year
- Women complaining of heavy menstrual bleeding over several consecutive cycles
- Women without structural or histological abnormality of the uterus, or with fibroids less than 3 cm in diameter which are causing no distortion of the uterine cavity (eligible for pharmaceutical treatment according to the NICE guideline 2007)
- Informed consent (where required by laws or regulations)
Who cannot join
- The contraindications and warnings of the respective Summary of Product Characteristics (Mirena, combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug, or anti-fibrinolytic agent) must be followed.
- Women taking hormone replacement therapy
- Women with symptoms such as intermenstrual or post-coital bleeding, unless an endometrial biopsy has been performed and pathology excluded
- Women with fibroids that are palpable abdominally or who have intra-cavity fibroids and/or whose uterine length as measured at ultrasound or hysteroscopy is greater than 12 cm (NICE guideline 2007)
- Women on anticoagulative therapy or other treatment (including e.g. Copper IUD use) known to cause menorrhagia
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
About this study
Official title: MiCo - Mirena or Conventional Medical Treatment for Menorrhagia
The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Mirena in treatment of prolonged or heavy menstrual bleeding (Menorrhagia) under daily-life treatment conditions.
It is planned to conduct the study in about 10 countries with a total of 1000 patients. In several countries, a comparator group will also be documented.
For each patient, an initial visit and one to three follow-up visits after about 3, 6 and 12 months will be documented by the treating physician on the case report form. Observations include the patient's demographic parameters (date of birth, height, weight, race and smoking habits), previous contraceptives and menorrhagia treatment, gynaecological history, baseline menstruation, result of insertion, concomitant medications and diseases as well as menorrhagia symptoms. Overall treatment success will be evaluated at the end of treatment including number of weeks until improvement and reduction of menstrual bleeding with respect to duration and severity, and patient's satisfaction.
Read the detailed description
The "MiCo - Mirena or conventional medical treatment for menorrhagia" study consist of two parts, MiCo Asia-Pacific and MiCo MA0901 (Rest of World).
Data from both parts will be analysed in separate pools as well as in a global pool. The trial alias are IMPACT Nos. 14697, 14536 (NCT01085487).
- Conditions
- Menorrhagia
- Being tested
- Levonorgestrel (Mirena, BAY86-5028), Conventional medical treatment
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel (Mirena, BAY86-5028)Drug
Women using Mirena for treatment of menorrhagia
Conventional medical treatmentDrug
Women using combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug
Conventional medical treatmentDrug
Women using anti-fibrinolytic agent for treatment of menorrhagia
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Levonorgestrel (Mirena, BAY86-5028) | |
| Group 2 | Not described Receives: Drug: Conventional medical treatment | |
| Group 3 | Not described Receives: Drug: Conventional medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative continuation rate stratified by history of previous treatment(s) for menorrhagia
Measured: at 12 months
Secondary outcomes (4)
Bleeding pattern
Measured: at 12 months
Patient satisfaction at end of documentation
Measured: at 12 months
Impact of the therapy in terms of patient-derived health outcomes (validated patient questionnaire)
Measured: at 12 months
Adverse events collection
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startNov 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 647 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864136
- Sponsor's protocol ID
- 14697
- Other IDs
- MA0701, MA0901 - non-East Asia
- Status last verified
- Jun 2015
- First submitted
- 17 Mar 2009
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee BS, Ling X, Asif S, Kraemer P, Hanisch JU, Inki P. Levonorgestrel-releasing intrauterine system versus conventional medical therapy for heavy menstrual bleeding in the Asia-Pacific region. Int J Gynaecol Obstet. 2013 Apr;121(1):24-30. doi: 10.1016/j.ijgo.2012.10.028. Epub 2013 Jan 20.
PubMed 23340271
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MiCo - Mirena or Conventional Medical Treatment for Menorrhagia
- ClinicalTrials.gov ID
- NCT00864136
- Acronym / sponsor ID
- 14697
- Conditions
- Menorrhagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 647 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Mirena in treatment of prolonged or heavy menstrual bleeding (Menorrhagia) under daily-life treatment conditions.
It is planned to conduct the study in about 10 countries with a total of 1000 patients. In several countries, a comparator group will also be documented.
For each patient, an initial visit and one to three follow-up visits after about 3, 6 and 12 months will be documented by the treating physician on the case report form. Observations include the patient's demographic parameters (date of birth, height, weight, race and smoking habits), previous contraceptives and menorrhagia treatment, gynaecological history, baseline menstruation, result of insertion, concomitant medications and diseases as well as menorrhagia symptoms. Overall treatment success will be evaluated at the end of treatment including number of weeks until improvement and reduction of menstrual bleeding with respect to duration and severity, and patient's satisfaction.
Detailed description
The "MiCo - Mirena or conventional medical treatment for menorrhagia" study consist of two parts, MiCo Asia-Pacific and MiCo MA0901 (Rest of World).
Data from both parts will be analysed in separate pools as well as in a global pool. The trial alias are IMPACT Nos. 14697, 14536 (NCT01085487).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Levonorgestrel (Mirena, BAY86-5028) |
| Group 2 | – | Drug: Conventional medical treatment |
| Group 3 | – | Drug: Conventional medical treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with a diagnosis of idiopathic menorrhagia can be enrolled after decision for treatment has been made.
Key inclusion criteria (4 listed)
- Women between the ages of 18-45 (inclusive) not intending to get pregnant during the next year
- Women complaining of heavy menstrual bleeding over several consecutive cycles
- Women without structural or histological abnormality of the uterus, or with fibroids less than 3 cm in diameter which are causing no distortion of the uterine cavity (eligible for pharmaceutical treatment according to the NICE guideline 2007)
- Informed consent (where required by laws or regulations)
Key exclusion criteria (5 listed)
- The contraindications and warnings of the respective Summary of Product Characteristics (Mirena, combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug, or anti-fibrinolytic agent) must be followed.
- Women taking hormone replacement therapy
- Women with symptoms such as intermenstrual or post-coital bleeding, unless an endometrial biopsy has been performed and pathology excluded
- Women with fibroids that are palpable abdominally or who have intra-cavity fibroids and/or whose uterine length as measured at ultrasound or hysteroscopy is greater than 12 cm (NICE guideline 2007)
- Women on anticoagulative therapy or other treatment (including e.g. Copper IUD use) known to cause menorrhagia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levonorgestrel (Mirena, BAY86-5028)Women using Mirena for treatment of menorrhagia | Drug | Group 1 |
| Conventional medical treatmentWomen using combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug | Drug | Group 2 |
| Conventional medical treatmentWomen using anti-fibrinolytic agent for treatment of menorrhagia | Drug | Group 3 |
Primary outcome
Cumulative continuation rate stratified by history of previous treatment(s) for menorrhagia
Time frame: at 12 months
4 secondary outcomes
Bleeding pattern
Time frame: at 12 months
Patient satisfaction at end of documentation
Time frame: at 12 months
Impact of the therapy in terms of patient-derived health outcomes (validated patient questionnaire)
Time frame: at 12 months
Adverse events collection
Time frame: at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
- Derived from this study: PubMed 23340271Lee BS, Ling X, Asif S, Kraemer P, Hanisch JU, Inki P. Levonorgestrel-releasing intrauterine system versus conventional medical therapy for heavy menstrual bleeding in the Asia-Pacific region. Int J Gynaecol Obstet. 2013 Apr;121(1):24-30. doi: 10.1016/j.ijgo.2012.10.028. Epub 2013 Jan 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menorrhagia, run by Bayer at 8 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China, Hong Kong, Indonesia, Malaysia, Pakistan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative continuation rate stratified by history of previous treatment(s) for menorrhagia (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00864136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2015.